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NCT Number: NCT07518368

Sleep Optimization to Aid in Recovery Digital Program

The purpose of this pilot study is to evaluate the usability and feasibility of SOAR (Sleep Optimization to Aid Recovery), a brief and self-guided digital program designed to share evidence-based sleep hygiene information with individuals seeking treatment for an eating disorder. The SOAR program delivers well-established recommendations promoted by the National Sleep Foundation and other professional sleep health organizations. The purpose of this study is not to test a new treatment or intervention per se, but rather to examine how effectively this existing information can be delivered through a digital platform to people preparing for or engaged in eating disorder treatment. By providing these evidence-based strategies in a user-friendly and accessible format, SOAR aims to support healthy sleep habits that may enhance overall well-being and facilitate recovery.

The investigators will compare SOAR against a control condition, which would be no intervention (treatment-as-usual). Participants randomized to the control will receive access to SOAR after the follow-up period has ended, if they wish to use it.

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Key information

Conditions

Sleep Health Binge Eating Bulimia Disordered Eating Feeding and Eating Disorders Hyperphagia Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Sleep Disturbances Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older,
  • Initiating treatment for an eating disorder (e.g., currently on a waitlist for eating disorder treatment, scheduled to start treatment, completed an intake, or started treatment within the past two weeks for an eating disorder),
  • Able to access the internet

Exclusion criteria

  • None

Treatment and study plan

SOAR

Behavioral

SOAR is administered using the REDCap platform. It consists of a series of videos about the science behind the link between eating disorders and sleep and best practices and tips for sleep health recommended by leading sleep health organizations. SOAR includes sleep hygiene information, videos on stimulus control (a best practices intervention for insomnia), and instructions for setting a regular sleep/wake time. At the end of the program, users will create a sleep action plan using the information they learned from SOAR.

Primary outcomes

  1. PROMIS Sleep Disturbance

    Time frame: Baseline and one-month follow-up

    Scores range from 8 to 40 with higher scores indicating greater sleep disturbance.

  2. PROMIS Sleep Impairment

    Time frame: Baseline and one-month follow-up

    Scores range from 8 to 40 with higher scores indicating greater impairment from sleep problems.

Secondary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: Within 24 hours post-intervention

    Scores range from 1 to 5 with higher scores indicating greater acceptability of the intervention.

  2. Intervention Appropriateness Measure (IAM)

    Time frame: Within 24 hours post-intervention

    Scores range from 1 to 5 with higher scores indicating greater appropriateness of the intervention.

  3. Feasibility of Intervention Measure (FIM)

    Time frame: Within 24 hours post-intervention

    Scores range from 1 to 5 with higher scores indicating greater feasibility of the intervention.

  4. System Usability Scale (SUS)

    Time frame: Within 24 hours post-intervention

    Scores range from 0 to 100 with higher scores indicating greater usability of the intervention.

  5. Sleep Hygiene Index

    Time frame: Baseline and one-month follow-up

    Scores range from 13-65 with higher global scores indicative of more maladaptive sleep hygiene practices.

Other outcomes

  1. Sleep Health (RU-SATED)

    Time frame: Baseline and one-month follow-up

    Scores range from 0 to 14 with higher scores indicating better sleep health

  2. Eating Disorder-15

    Time frame: Baseline and one-month follow-up

    Scores for the two factors (Weight & Shape Concerns and Eating Concerns) and the total score are presented as an average score (between 0 to 6) with a higher score indicating more eating-disordered cognitions and behaviors.

  3. Generalized Anxiety Disorder-7

    Time frame: Baseline and one-month follow-up

    Scores range from 0 to 21 with higher scores indicate greater generalized anxiety disorder pathology.

  4. Patient Health Questionnaire-8

    Time frame: Baseline and one-month follow-up

    Scores range from 0 to 24 with higher scores indicating greater depressive pathology. The suicidality question from the PHQ-9 will not be administered.

  5. Self-Efficacy Scale

    Time frame: Baseline and one-month follow-up

    Scores range from 10 to 40 with higher scores indicating greater self-efficacy.

  6. Clinical Impairment Asssessment

    Time frame: Baseline and one-month follow-up

    Scores range from 0 to 48 with higher scores indicating greater impairment from eating disorder symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosha Feizi Lighvan, B.A.

CONTACT

[email protected]

702-895-2099

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Registry information

Acronym: SOARPilot

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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